Week 7: Why so CERUS?

Mohin P -

This week brought some great news that made all the work lately feel really worth it. Dr. G, our medical director, likes the abstract drafts I had been working on. Hearing that from someone with so much experience was honestly a huge boost. Even better, there is a chance I might get to work on another abstract, this time focusing on High School Donor Reactions. I will have to wait a bit longer though, since they still need to pull the data for that project. So in the meantime, I shifted gears and dove into something completely new: preparing for a business proposal on Intercept Fibrinogen Complex (IFC) and Pathogen Reduced Platelets.

Learning about IFC was eye-opening. CERUS is currently the only FDA-approved and CE (Conformité Européenne AKA Europe’s FDA) marked vendor for pathogen reduction for cryoprecipitate (the portion of plasma [the liquid part of the blood] rich with clotting factors]). There was another option before, called Mirasol Platelets in Plasma (MIPLATE), and South Texas Blood and Tissue was actually considering it. But that system ended up getting shut down, so now CERUS’s IFC is up for consideration with no competition.

Here is how it works: a special compound called amotosalen is added to the cryoprecipitate units (cryo), and then they are exposed to UVA light (a type of ultraviolet light). The amotosalen binds to any nucleic acids, like DNA or RNA, inside most viruses, bacteria, or parasites, basically switching them off so they cannot reproduce or cause infections. Like regular cryo, IFC has important proteins like fibrinogen, factor XIII, and von Willebrand factor to help with clotting and prevent hemorrhages, which is huge for patient safety.

This is the chemical structure for amotosalen, which is a type of psoralen. Psoralens are naturally found in various fruits and vegetables as a protection mechanism against pathogens. Amotosalen binds and intercalates or docks between nucleic acid base-pairs. As you might see, the structure seems diagonal in 2D but is straight in 3D. This allows amotosalen to crosslink pathogen nucleic acids, preventing further replication and blocking transcription and translation. In other words, amotosalen corrupts the instructions for the pathogens to attack and reproduce, so they kind of just exist. Luckily, platelets and cryo units do not rely on nucleic acids for therapeutic efficacy, so they are not damaged in the process.

There are a lot of upsides. These cryo units have a post-thaw shelf life of five days, meaning they can be transfused immediately instead of waiting around to defrost. If they are not used right away, they can just go back into inventory, minimizing waste. Clinical studies from all over the nation, from Stanford to the University of Florida, really back this up. Their research showed that using pathogen reduced cryo units improves both safety and efficiency while causing less waste — a major win for hospitals and patients. Also, if we get the UVA illuminator for IFC cryo units, we can also use it to create pathogen reduced platelets, which many blood centers and hospitals already use. CERUS is even working on pathogen reduced RBCs and even pathogen reduced whole blood units that use the same illuminator, which means South Texas Blood and Tissue can be among the first to implement these new technologies.

Of course, there are still challenges. The cost is definitely higher compared to regular cryo, and adding an extra processing step means facilities have to be really organized. But when you balance the risks and benefits, especially when it comes to preventing serious infections, it feels like a step in the right direction. Especially in the current climate where more and more doctors are aware of and solely request pathogen reduced products, South Texas Blood and Tissue might get left behind if this is not implemented in the near future.

Overall, my project is moving along, but this week definitely pushed me to think more critically outside of my usual scope of high school blood donations. I had to connect scientific research, public health needs, and business strategy all at once, which was harder than I thought it would be. The biggest obstacle right now is just time: waiting for the new donor reaction data and continuing to piece together everything I have learned for that business proposal.

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Comments:

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    Jacob Lopez
    Congrats on the preliminary approval for those drafts, I hope you can continue to see the fruits of your labor as you continue to leave a positive impact on the community. I didn't even know there were options for pathogen reducing. I think it's amazing what you've been able to do with this data from different regions. You mentioned cost was a concern when it comes to utilizing pathogen reduced blood, is this something that may become a major issue in the future as it becomes more prevalent? Or do you know if companies are looking for ways to reduce the cost of such blood? It seems amazing that there's an option for this, but it wouldn't provide much benefit if it put companies out of business.
    mohin_p
    Thank you for the thoughtful comment! You’re absolutely right—cost is one of the biggest hurdles when it comes to implementing pathogen-reduced blood products. There’s definitely a significant upfront cost to switching to 100% pathogen-reduced IFC, but one approach we’re exploring is using it selectively for STAT orders and Massive Transfusion Protocols (MTPs). This way, we can minimize waste while still having safer products available for emergencies, which makes the investment much more cost-effective. CERUS, the company behind a major pathogen reduction technology, has actually been lobbying the FDA for years to shift blood product guidelines in favor of pathogen-reduced options. If that happens, they’ll likely raise prices significantly, so adopting the technology now could actually save money in the long run. We’re also considering CERUS subsidies, where they cover equipment costs in exchange for research blood products from South Texas Blood and Tissue. Overall, cost is always a factor with new blood tech, which is why it's crucial for blood banks to stay ahead of the curve before these solutions become standard (and expensive).

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